UMIN-CTR Clinical Trial

Public title

Efficacy of voice rest and voice therapy after vocal fold surgery

Acronym

Efficacy of voice rest

Scientific Title

Efficacy of voice rest and voice therapy after vocal fold surgery

Scientific Title:Acronym

Efficacy of voice rest

Region

Japan

Condition

The patients who will undergo laryngomicrosurgery for leukoplakia, carcinoma, vocal fold polyp, polypoid and cyst.

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this clinical trials is to examine the effect of voice rest in postsurgical voice therapy on wound healing of vocal folds. This clinical trials will tell the effects of mechanical stress on vocal fold tissue remodeling and help to prevent from phonotrauma. This will also contribute to the effective postsurgical rehabilitation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II

Primary outcomes

Stroboscopic examination, aerodynamic assessment, acoustic analysis and voice handicap index(VHI)-10 are performed at 24weeks after surgery.
Stroboscopic examination evaluates normalized mucosal wave amplitude(NMWA)and normalized
glottal gap(NGG).Aerodynamic assessment includes maximum phonation time(MPT),mean flow rate(MFR) and AC/DC ratio: vocal efficiency index. Acoustic analysis evaluates pitch perturbation quotient(PPQ),amplitude perturbation quotient(APQ),noise to harmonic ratio(NHR).The above parameters are compared between the groups.

Key secondary outcomes

Same assessments are needed at 4,12,weeks after suegery.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The patients undergo voice rest for 3 days,then start voice therapy from day4 after surgery.They undergo voice therapy for 6weeks. Assessments are needed at 4,12,24weeks.

Interventions/Control_2

The patients undergo voice rest for 7 days,then start voice therapy from day8 after surgery.They undergo voice therapy for 6weeks. Assessments are needed at 4,12,24weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects are the patients who will undergo laryngomicrosurgery for leukoplakia, carcinoma, vocal fold polyp, polypoid and cyst at Kyoto University Hospital and agree for the participation in this trials.

Key exclusion criteria

*the patients with a history of radiation therapy for the larynx.
*the patients with a heart or lung disease, who easily become tired upon phonation.
*the patients who are pregnant or children.
*the patients who cannot follow the doctor's instruction.
*the patients who are judged as inappropriate candidates by the doctor.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Shigeru Hirano

Organization

Graduate School of Medicine
Kyoto University

Division name

Department of Otolaryngology Head and Neck Surgery

Zip code

Address

54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507

TEL

075-751-3346

Email

hirano@ent.kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Mami Kaneko

Organization

Graduate School of Medicine

Division name

Department of Otolaryngology Head and Neck Surgery

Zip code

Address

54 Kawahara-cho, Shogoin, Sakyo-ku Kyoto 606-8507

TEL

075-751-3346

Homepage URL

Email

m_kaneko@ent.kuhp.kyoto-u.ac.jp

Institute

Department of Otolaryngology Head and Neck Surgery
Graduate School of Medicine
Kyoto University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学病院（京都府）

Date of disclosure of the study information

2012

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Whole enrolled case: 50

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

08

Month

06

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

02

Day

Last follow-up date

2016

Year

02

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

No problems.

Registered date

2012

Year

07

Month

02

Day

Last modified on

2016

Year

03

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009794